Law and Ethics of the Pharmaceutical Industry (eBook)

Cover 1
The Law and Ethics of the Pharmaceutical Industry 4
Preface 6
Acknowledgements 10
List of Boxes, Figures and Tables 12
Table of Contents 14
Part A: The Definition of Standards 20
Chapter 1 The Pharmaceutical Industry and Its Products 22
1.1 The Concept of a Pharmaceutical Product 22
1.2 The Development of the Pharmaceutical Industry 24
1.3 The Unique Nature of the Pharmaceutical Field and the Need for Rules 26
1.4 The Various Roles of the Pharmaceutical Industry Today 29
1.5 Types of Industrial Firms Engaged in the Pharmaceutical Field 29
1.5.1. Research-based companies 30
1.5.2. GenericŽ manufacturers 31
1.6. The Reputation of the Pharmaceutical Industry 33
Chapter 2 Sources of Standards for Business and Industry Generally 36
2.1. Grounds for Defining and Respecting Business Standards 36
2.1.1. General 36
2.1.2. A basis in human rights 38
2.1.3. The notion of business ethics 41
2.2. Laws and Regulations Relating to Business and 50
2.2.1. Contract and sale of goods 50
2.2.2. The law of tort and non-contractual liability 52
2.2.3. Consumer protection legislation 54
2.2.4. Intellectual property trademarks, patents and data exclusivity
2.2.5. Social and employment law 73
2.2.6. Environmental law 75
2.2.7. Company law and reporting obligations 77
2.3. Competitive and Financial Pressures 78
2.4. Political Influences 79
2.5. The Influence of Litigation 80
2.6. Public Relations and the Public Image 83
2.7. The Location of the Company Conscience 85
2.8. Company and Industry Codes of Behaviour 87
2.8.1. Types of codes 87
2.8.2. Style and content of codes 92
2.8.3. The usefulness of codes 93
2.9. Transnational Corporations and Influences 95
2.10. Corporate Social ResponsibilityŽ and Government 100
Chapter 3 Sources of Standards Specific to the Pharmaceutical Industry 104
3.1. General Considerations 104
3.2. Standards Originating from Pharmacy Practice 105
3.2.1. A basis in trust 105
3.2.2. Professional pharmacy in industry 108
3.2.3. Allocation of general pharmaceutical responsibilities 110
3.2.4. Trade interests vs. professional interests 111
3.3. Standards Originating from Medical Law and Ethics 114
3.3.1. Primary duty to the patient 114
3.3.2. Current medical expertise 114
3.3.3. The duty of care 115
3.3.4. Confidentiality 116
3.3.5. Allocation of general medical responsibility 118
3.3.6. A code of ethics for pharmaceutical physicians? 120
3.4. Standards set by Pharmaceutical Legislation and Regulation 122
3.4.1. The evolution of modern drug regulation 122
3.4.2. Policy, legislation and regulation 127
3.4.3. Issues of responsibility and liability 132
3.4.4. Relationship of the applicant to the regulatory agency 134
3.4.5. Old vs. new products 138
3.4.6. The global coverage of law and regulation 139
3.4.7. Criticism of regulatory standards deregulation
3.4.8. The role of the WHO 148
3.5. Self-regulation in the Pharmaceutical Industry 151
Part B: Acceptance and Implementation of Standards 154
Chapter 4 Ensuring Quality, Safety and Efficacy 156
4.1. Pre-marketing and Post-marketing Duties 156
4.2. The Manufacturing and Quality Control of Drugs 160
4.2.1. The legal concept of quality 160
4.2.2. Establishment and maintenance of quality standards 161
4.2.3. Packaging and distribution 168
4.2.4. Nature and extent of quality defects 169
4.2.5. Liability for quality defects 170
4.3. Establishing the Safety of Drugs 173
4.3.1. The legal concept of safety 173
4.3.2. Physical, social and mental injury 176
4.3.3. Initial evidence of safety 178
4.3.4. Adverse reaction monitoring systems 181
4.3.5. Role and duties of industry in ADR monitoring 184
4.3.6. Safety in overdose 187
4.3.7. Pregnancy, lactation and beyond9 187
4.3.8. Relevance of regulatory approval to civil liability for injury 189
4.4. Establishing the Efficacy of Drugs 192
4.4.1. The legal concept of efficacy 192
4.4.2. Warranties and guarantees 193
4.4.3. Efficacy of oldŽ drugs 196
4.4.4. Proof of efficacy 197
4.4.5. Publication bias 198
4.4.6. Efficacy and compassion 199
Chapter 5 The Industry As a Source of Information, Persuasion and Education 202
5.1. Need Marketing be Controlled by Law? 202
5.2. Marketing Codes: from WHO onwards 203
5.3. Can Marketing be Controlled by Law and Rule Making? 204
5.4. Basic Information 213
5.5. Persuasion 217
5.5.2. Common points of dispute 218
5.5.3. The detailman 221
5.5.4. Advertising of prescription items to the public (D.T.C.Ž) 225
5.6. Disease Mongering 226
5.7. Financial Incentives 228
5.8. Education 230
5.9. Miscellaneous Forms of Promotion 231
5.10. Future Law and Policy 233
Chapter 6 Pharmaceutical Pricing and Profits 234
6.1. Pharmaceutical Prices and Controversies 234
6.2. The Level of Spending 238
6.3. The Manufacturer’s Costs 239
6.4. The Ethics of Pricing and Profits 241
6.5. How does Society Control the Prices of Medicines? 243
6.5.1. Calculation of a fairŽ supply price 244
6.5.2. Reference pricing (Huttin 2002) 245
6.5.3. Economic evaluation of prices 246
6.5.4. Control of profits and expenses 247
6.6. Differential and Equity Pricing 248
6.7. Parallel Importation and the Question of Re-importation 248
6.8. Future Approaches to Pricing 253
Chapter 7 The Industry as Innovator 254
7.1. Innovation and Duty 254
7.2. The Innovation Controversy 257
7.3. Statistics and Analyses 258
7.3.1. The real cost of a new drug 258
7.3.2. Research expenditure within the company 259
7.3.3. Innovation trends over time 261
7.3.4. The spectrum of drugs reaching the market 263
7.3.5. The non-industrial role in drug innovation 266
7.4. Future Trends and Corrective Measures 268
7.4.1. Should the innovation process change? 268
7.4.2. Can industry adapt? 271
7.4.3. Is outside action necessary? 271
7.4.4. The Drugs for Neglected Diseases Initiative 272
7.4.5. Governments, communities and donors 273
7.4.6. Independent non-profit research centres 275
7.4.7. Official incentives to true innovation 276
7.4.8. A total approach to innovation 279
Chapter 8 The Industry and the Developing World 282
8.1. Pharmaceuticals in Developing Countries 282
8.2. The Basis of Duty for Industry 284
8.3. Industrial Performance in the Third World 288
8.4. An Overview of Obligations 290
8.5. Quality, Safety and Efficacy 291
8.6. Access, Prices and Affordability 292
8.7. Research and Development 296
8.8. Information and Education 298
8.9. Clinical Investigation in Developing Countries 298
8.10. Partnerships and Organizational Links 301
8.11. Donations 304
8.12. Essential Drugs 306
8.13. Counterfeit and Substandard Drugs 307
8.14. Perspectives 307
Chapter 9 Special Situations 310
9.1. Ethics of Animal Studies 310
9.2. Ethics of Human Studies1 313
9.2.1. General principles of human experimentation 313
9.2.2. Sponsor and investigator 314
9.2.3. The responsibilities of the sponsor 317
9.3. Self Medication 320
9.3.1. The nature of self-medication 320
9.3.2. Emergent concepts in self-medication 323
9.3.3. Promotion and labelling 325
9.3.5. Future developments 329
9.3.4. Liability for self-medication products 328
9.4. Manufacturing and Supply of Vaccines 329
9.5. Blood and Blood Products 333
9.6. Controlled Substances 335
9.6.1. Legal instruments governing controlled substances 335
9.6.2. Duties of the manufacturer 336
9.6.3. Ethics and controlled substances 338
9.7. Alternative and Miscellaneous Medicines 339
9.7.1. Products on the borderline 339
9.7.2. Nutritional SupplementsŽ in the US 340
9.7.3. Miscellaneous products 341
9.8. Orphan Drugs 345
9.9. Veterinary Drugs 346
Chapter 10 The Duties of the Generic Manufacturer 348
10.1. The Nature of the Generic Drug Industry 348
10.2. The Significance of the Generic Industry 349
10.3. Governments, Laws and Generics 350
10.4. Generic Drugs in US Law 351
10.5. Generic Drugs in the European Union 353
10.6. Generic Drugs in India 354
10.7. Generics and Data Exclusivity 356
10.8. Generic Substitution 357
10.9. Generic Biologicals, Biogenerics and Biosimilars 359
10.10. The Future Status of the Generic Pharmaceutical Industry 361
Chapter 11 The Pharmaceutical Industry and Social Controversy 364
11.1. The Ethics of Contraception 364
11.2. The Morning after PillŽ 365
11.3. Abortifacients 366
11.4. Patenting of Biological Materials 367
11.5. Future Involvement in Social Controversy 369
Chapter 12 Postscript: The Way Ahead 372
12.1. Medicines in the Mist 372
12.2. The Trouble with Law 372
12.3. The Trouble with Governments 374
12.4. The Trouble with Corporations 377
12.4.1. The discrepancy 377
12.4.2. The perils of success 378
12.4.3. The sense of impregnability 379
12.4.4. Attitude to the law 379
12.4.5. Contempt 381
12.5. Time for Change 381
12.5.1. Is change essential? 381
12.5.2. Is change possible? 384
12.5.3. The flow of money 384
12.5.4. Bigger, better and broader? 385
12.5.5. Trends to change? 386
12.5.6. Forwards 386
List of Selected References 388
Index 412